The document reviews and summarizes preliminary responses from Tribal Nations regarding proposed changes to the Common Rule, particularly those affecting biospecimens and the use of a single Institutional Review Board (IRB) for multisite research. Thirteen responses were analyzed, with a strong emphasis on protecting tribal sovereignty, cultural values, and ethical considerations in research involving tribal members.
Key findings indicate broad support among respondents for expanding the definition of “human subject” to include non-identified biospecimens, reflecting the desire to ensure appropriate cultural and ethical protections for materials considered sacred within tribal traditions. Conversely, there was unanimous opposition to the concept of broad consent for secondary biospecimen use, primarily due to concerns about inadequate tribal oversight, potential harms, and insufficient opportunities for tribal members to opt out. There was also unanimous support for restricting IRB waivers of consent, with tribal representatives insisting that consent should always be obtained. Additionally, the mandate for a single IRB in multisite studies was uniformly opposed, with tribes expressing that such a requirement would erode their authority, ignore unique cultural risks, and fail to ensure adequate review by those familiar with tribal values. Overarching throughout the responses is a call for revised proposals that explicitly recognize and respect the governance and oversight rights of tribal nations in research conducted on their lands or involving their citizens.
